Vincristine-induced Peripheral Neuropathy in Adult Survivors of Childhood and Adolescent Leukemia

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— CIPN-LEA  

Official title:

Long-term Evaluation of Vincristine-induced Peripheral Neuropathy in Adult Survivors of a Multicenter Prospective Cohort of Childhood and Adolescent Leukemia (LEA Cohort): a Multicenter Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759052
• Other study ID #: PHRC IR 2021 BALAYSSAC
• Secondary ID: 2022-A01758-35
• Status: Recruiting
• Start date: May 5, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vincristine is a major anticancer agent in the management of hematological malignancies. One of the main side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a characteristic side effect of neurotoxic anticancer drugs. CIPN associated with vincristine is typically characterized by distal and symmetrical sensory symptoms (dysesthesia and paresthesia). Motor and vegetative symptoms can also be found. The prevalence of CIPN associated with vincristine during treatment ranges from 12 to 100% in children (depending on the endpoint).

The aim of this cross-sectionnal study will be to explore the CIPN prevalence and severity in adult survivors of childhood leukemia and having been treated by vincristine.

Description:

Adult survivors of chidlhood leukemia and having been treated by vincristine will be contacted from the French childhood cancer survivor study for leukaemia (LEA Cohort) in order to seek their participation agreement.

Thereafter patients will received a self-administered questionnaire exploring the chemotherapy-induced peripheral neuropathy and related comorbidities (pain, neuropathic pain, anxiety, depression, health-related quality of life, substance use, physical activity, deprivation). Oncological and sociodemographic characteristics of participants will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient (> 18-year) who received a vincristine-based chemotherapy for hematological malignancy in childhood

Exclusion Criteria:

• Secondary cancer (leukemia and/or cancer)

• Active oncological pathology

• Current cancer treatment

• Adults protected

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Leukemia
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• self-administered questionnaire
Patients will answer to a self- administered questionnaire exploring chemotherapy-induced peripheral neuropathy and related comorbidities

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitive chemotherapy-induced peripheral neuropathy	Scores of the sensitive subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst	day 1
Secondary	Motor chemotherapy-induced peripheral neuropathy	Scores of the motor subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst	day 1
Secondary	Pain severity	Scores of pain severirty assessed with a visual analogic scale scores : 0 no pain - 10 maximal pain	day 1
Secondary	Neuropathic pain	Scores of the DN4 interview questionnaire (Douleur neuropathique 4 questions) Scores : 0 least - 7 worst Threshold for neuropathic pain : 3	day 1
Secondary	Ongoing analgesic treatment	Reporting of ongoing analgesic treatment declared by the patient	day 1
Secondary	Anxiety severity	Scores of the anxiety subscale of the HADS questionnaire (Hospital anxiety and depression scale) Anxiety scores: 0 least - 21 worst Normal scores: =7 Borderline or suggestive of possible anxiety: 8-10 Indicative of anxiety: =11	day 1
Secondary	Depression severity	Scores of the depression subscale of the HADS questionnaire (Hospital anxiety and depression scale) Depression scores: 0 least - 21 worst Normal scores: =7 Borderline or suggestive of possible depression: 8-10 Indicative of depression: =11	day 1
Secondary	Health-related quality of life	Scores of the SF36 questionnaire (short-form 36) for each item: 0 worst - 100 best	day 1
Secondary	Physical activity and sedentarity	GPAQ questionnaire (Global Physical Activity Questionnaire) Work-related physical activity (minutes) Leisure-related physical activity (minutes) Time spent sitting (minutes)	day 1
Secondary	Deprivation	Scores of the EPICES questionnaire (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé) Scores: 0 best - 100 worst	day 1
Secondary	Use of legal and illegal psychoactive drugs	Reporting of legal psychoactive drug use (alcohol, tobacco, e-cigarette, psychoactive medication, cannabidiol, and other), and illegal psychoactive drug use (cannabis, and other)	day 1
Secondary	Oncological characteristics	Type of hematological malignancy and date of diagnosis ; Chemotherapy received: vincristine (date of last course and cumulative dose), anthracyclines (cumulative dose) ; Radiation therapy received: central nervous system irradiation and total dose, total body irradiation and total dose ; Hematopoietic stem cell (HSC) transplant: autograft or allograft, and date of transplant(s) ; Relapse (date)	day 1
Secondary	Oncological characteristics	Type of hematological malignancy, date of diagnosis, and relapse (date)	day 1
Secondary	Anticancer drugs received	vincristine (date of last course and cumulative dose), and anthracyclines (cumulative dose)	day 1
Secondary	Radiation therapy received	Central nervous system irradiation (total dose), total body irradiation (total dose)	day 1
Secondary	Hematopoietic stem cell transplant	Autograft or allograft, and date of transplant(s)	day 1
Secondary	Sociodemographic characteristics	Age at the time of the response to the study questionnaire ; Age at diagnosis of hematological malignancy ; Gender ; Weight, height, body surface area, weight-for-age and sex-percentile at diagnosis ; Weight, height and BMI at time of response ; Intercurrent pathology at time of response ; socio-professional group	day 1